About this trial
In a pilot study, water vapor therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure for benign prostatic hyperplasia, but often requiring oral ± intravenous sedation or a transrectal prostatic block. Therefore, pain management during Rezum therapy remains a challenge and may lead to the use of pain control protocols and general anesthesia, limiting in some ways the concept of a minimally invasive ambulatory surgical approach. The Schelin® catheter (ProstaLund AB, Lund, Sweden), approved by the European Medicines Agency, is a device for injecting analgesic drugs directly into the prostate via the trans-urethral route, providing more effective local anesthesia and avoiding the need for transrectal route or general anesthesia. This catheter is therefore of crucial importance in offering to our patients an ultra-minimally invasive treatment, associated with a reduction in room occupancy time, outpatient surgery time, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery. Our hypothesis is that the REZUM procedure under local anesthesia could be associated with a \>20% reduction in operating room occupancy time compared to procedures performed under general anesthesia.
Eligibility criteria
Qualifiers
Patients referred for symptomatic benign prostatic hyperplasia (BPH)
Men between 45 and 80 years of age
IPSS > 13
Qmax <15 ml/s
Disqualifiers
Patients with a history of prostate cancer
Patient with history of BPH surgery
Patients with a history of neurological bladder disease
Patient with history of urethral stricture
Trial design
Treatments tested in this trial
- water vapor therapy under general anesthesia
- water vapor therapy under local anesthesia